FDA.reportPublic FDA data

NDC 59399-160 - Artificial Tears

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59399-160
Package NDCs from labels
59399-160-15
Manufacturer
Akorn | Avantor Performance Materials International, Inc.
Effective date
2022-11-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Artificial Tears - Akorn | Avantor Performance Materials International, Inc.Akorn | Avantor Performance Materials International, Inc.2022-11-03OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59399-160-15Artificial Tears1 in 1 CARTONSOLUTION/ DROPS15
59399-160-15Artificial Tears15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59399-160ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN]52 package rows20221104_2ef16864-97cb-4dfe-9461-cba156144c69.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyvinyl AlcoholACTIVE INGREDIENT532B59J990ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Polyvinyl AlcoholACTIVE MOIETY532B59J990ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Sodium Phosphate, Monobasic, AnhydrousINACTIVE INGREDIENTKH7I04HPUUARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 44 of 110 · 2,190 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime 4X Medicated CreamBENZOCAINERite Aid21645ed1-2dc0-223a-e063-6394a90ab0212025-11-21WarningsExact identifier
unii: F5UM2KM3W7
4x Medicated Gum CreamBENZOCAINEAlbertsonsb81a308c-9c30-0e3d-e053-2a95a90a15d22025-11-21WarningsExact identifier
unii: F5UM2KM3W7
pre fenseBENZALKONIUM CHLORIDEPrefense LLCfad70060-8bb6-4b06-a353-666132f64c262025-11-21WarningsExact identifier
unii: F5UM2KM3W7
pre fense unscentedBENZALKONIUM CHLORIDEPrefense LLCa59e9bbf-b60e-970a-e053-2a95a90aaa5e2025-11-21WarningsExact identifier
unii: F5UM2KM3W7
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
AMERIDERMBZKSHIELD LINE LLC440b711a-de12-2d28-e063-6394a90ae42a2025-11-20WarningsExact identifier
unii: F5UM2KM3W7
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Aero Care Handy Quat Antiseptic HandwashBENZALKONIUM CHLORIDEABC Compounding Co., Inc.ab015f59-160a-47d1-8d2f-fbe1b23177b32025-11-19WarningsExact identifier
unii: F5UM2KM3W7
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
AMERISILKBZKSHIELD LINE LLC43f9775c-0448-243e-e063-6294a90a9e222025-11-19WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial Hydrating Coconut MilkBENZALKONIUM CHLORIDEHenkel Corporation43f9be89-b434-75da-e063-6294a90a18642025-11-19WarningsExact identifier
unii: F5UM2KM3W7
QS Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDERomaine Companies5e16f52d-3bf3-4897-bd3a-cf4e117583c92025-11-18WarningsExact identifier
unii: F5UM2KM3W7
Puri-San Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEPeople's Janitorial Supplyf0726bdd-9d2b-4383-af10-e2e0c5460e1e2025-11-18WarningsExact identifier
unii: F5UM2KM3W7
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCce0c8c6f-734a-400f-9b60-a3b1e263f25f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
unii: 451W47IQ8X
Cleansing WipesCLEANSING WIPESShenzhen Shierjie Biological Engineering Co., LTD43d6041f-18d1-b0e3-e063-6294a90a7c792025-11-17WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial Calm and SootheBENZALKONIUM CHLORIDEHenkel Corporatione81a2af6-fb4c-702d-e053-2995a90a6eaf2025-11-14WarningsExact identifier
unii: F5UM2KM3W7
Dial Antibacterial BarDIAL MOUNTAIN FRESH ANTIBACTERIAL BAR SOAPHenkel Corporation568518c8-e327-45a7-e054-00144ff8d46c2025-11-14WarningsExact identifier
unii: F5UM2KM3W7
4x Medicated Toothache and Gum CreamBENZOCAINEKrogera8c5090a-24f9-4e73-e053-2a95a90acca02025-11-14WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.